- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846351
Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes
May 1, 2013 updated by: Peter E. Liggett, New England Retina Associates
Visual and Anatomic Outcomes of Intravitreal Anti-VEGF Therapy for Exudative Age-related Macular Degeneration With Concurrent Significant Epiretinal Membrane.
Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.
Study Overview
Status
Completed
Detailed Description
Gass in 1987 described three cases of epiretinal membrane (ERM) associated with wet macular degeneration.
Since then we have seen that is not rare to find the coexistence of these entities.
An ERM may produce intrinsic disorganization of the outer retina leading to persistent increased macular thickness and/or edema.
This persistent edema may affect the effectiveness in the treatment of exudative age-related macular degeneration (eAMD).
Therefore, this study was designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.
Study Type
Observational
Enrollment (Actual)
16
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
age-related macular degeneration
Description
Inclusion Criteria:
- Significant epiretinal membrane
- Anti-VEGF treatment for age-related macular degeneration
Exclusion Criteria:
- Uveitis
- Macular disorders
- Diabetic retinopathy
- Vascular occlusions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity
Time Frame: 12 months
|
Evaluate the best visual acuity during the follow up.
|
12 months
|
Central macular thickness
Time Frame: 12 months
|
Evaluation of the retinal thickness changes with anti-VEGF treatment
|
12 months
|
Fluorescein angiogram
Time Frame: 12 months
|
Evaluation of changes in lesion size during follow-up.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nauman A Chaudhry, MD, New England Retina Associates
- Study Chair: Peter E Liggett, MD, New England Retina Associates
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAC270608
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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